NCT02471105

Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml

IOP and Tolerability Study of Preserved Bimatoprost 0.1% or Tafluprost Unit Dose Preservative Free 15microgram/ml, in Patients With OHT or Glaucoma Suitable for Prostaglandin Therapy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This cross-over study will investigate the efficacy and safety of BIMMD and TUDPF in a clinical setting.

Detailed description

* A prospective, randomized, investigator-masked, crossover comparison; * Ocular hypertension or glaucoma (XFG or POAG) patients and who consent to participate will be enrolled in this study * Patients will be scheduled for a screening visit IOP assessment (IOP measurements at 08:30, 12:30 and 16:30 (±1 hour). * Patients who are on therapy at the screening visit and who consent to participate will undergo a washout period for 4 weeks (depending on therapy) before the baseline visit; * Patient can under the washout period be given brinzolamide (Azopt) if needed, Azopt should then be discontinued 5 days before baseline visit; * After the screening visit (and after wash-outperiod for treated patients) patients will be scheduled to undergo a baseline visit IOP assessment (IOP measurements at 08:30, 12:30 and 16:30 (± 1 hour with a minimum of 3 hours between readings) and will then be randomized for Period 1 to receive either BIMMD drops once in the evening (20:30) or TUDPF drops once in the evening (20:30) for 3 month * After 3 month, patients will be switched for Period 2, to the opposite treatment (e.g. switched to either BIMMD or TUDPF) to be dosed in the evening; * After another 3 months they will undergo the final evaluation of IOP levels and of tolerability; * Intermediate safety visits may be scheduled at the discretion of the investigator.

Conditions

• Ocular Hypertension
• Glaucoma

Interventions

Type	Name	Description
DRUG	Preserved Bimatoprost 0.01%	Eye drops solution Topical use Once in the evening 3 months
DRUG	Tafluprost Unit Dose Preservative Free 15microgram/ml	Eye drops solution Topical use Once in the evening 3 months

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-05-01
• Completion: 2017-12-01
• First posted: 2015-06-15
• Last updated: 2016-05-12

Locations

7 sites across 5 countries: Austria, Belgium, Italy, Switzerland, United Kingdom